Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19

• Status: Enrolling by invitation
• Trial end date: 2028-12-01

Summary

Postacute sequelae of COVID-19 infection (PASC) are increasingly recognised complications and are defined by lingering symptoms, not present prior to the infection, typically persisting for more than 4 weeks. Cardiac symptoms due to post-acute inflammatory cardiac involvement affect a broad segment of people, who were previously well and may have had only mild acute illness (PASC-cardiovascular syndrome, PASC-CVS). Symptoms may be contiguous with the acute illness, however, more commonly they occur after a delay. Symptoms related to the cardiovascular system include exertional dyspnoea, exercise intolerance chest tightness, pulling or burning chest pain, and palpitations. Phenotypically, it is characterised by chronic perivascular and myopericardial inflammation. Cardiac symptoms may be accompanied by manifestations of other organ systems, including fatigue, brain fog, myalgias, skin and joint manifestations, etc, now commonly referred to as the Long COVID or PASC syndrome.

Early intervention with immunosuppression and antiremodelling therapy may reduce symptoms and myocardial impairment, by minimising the disease activity and inducing disease remission. Low dose maintenance therapy may help to maintain the disease activity at the lowest possible level. Clinical trials of immunosuppression in patients with viral myocarditis in advanced stages of heart failure have not shown an improved outcome, however there was an improvement of LVEF with antiremodelling therapy in patients with reduced function. The benefits of early initiations of antiremodelling therapy to reduce symptoms of exercise intolerance are well recognised, but not commonly employed outside the contexts of heart failure or hypertension. As most patients with inflammatory heart disease only have mild and nonspecific symptoms and few or no structural abnormalities, they are left untreated (standard of care). The aim of this study is to examine the efficacy of a combined immunosuppressive/antiremodelling therapy in patients with PASC symptoms and inflammatory cardiac involvement determined by CMR, to reduce the symptoms and inflammatory myocardial injury and thereby stop the progression to reduced LVEF, HF and death.

• Phase: Phase 3

Details

• Lead Sponsor: Valentina Puentmann
• Collaborators: Alcedis GmbH; Bayer
• Treatments: Losartan; Prednisolone